VERSATILE RP-HPLC METHOD DEVELOPMENT FOR QUANTITATIVE ESTIMATION OF TELMISARTAN AND RAMIPRIL IN ANIMAL PLASMA

  • Pranay Wal Pranveer Singh Institute of Technology, Kanpur-Agra-Delhi National Highway-2, Bhauti, Kanpur, India
  • Ruchi Tiwari Pranveer Singh Institute of Technology, Kanpur-Agra-Delhi National Highway-2, Bhauti, Kanpur, India
  • Ankita Wal Pranveer Singh Institute of Technology, Kanpur-Agra-Delhi National Highway-2, Bhauti, Kanpur, India
  • Gaurav Tiwari Pranveer Singh Institute of Technology, Kanpur-Agra-Delhi National Highway-2, Bhauti, Kanpur, India

Abstract

Objective: A fast, specific, and sensitive high-performance liquid chromatographic method has been developed and validated for the quantitative determination of unchanged Ramipril (RAM) and Telmisartan (TEL) in animal plasma.

Methods: Analytes were extracted from animal plasma, 250 µl of animal plasma sample were mixed with internal working standard (25 ngmL-1) with the further addition of chloroform (HPLC Grade, Merck). The clear organic layer was separated and reconstituted to 1 ml in mobile phase and analysed by HPLC. The method was validated and evaluated in terms of linearity, accuracy, precision, specificity, limit of detection and limit of quantitation.

Results: Absorption maxima of TEL and RAM was found to be 270 and 273 nm respectively. TEL and RAM with their respective internal standards (I. S.) were found to be well separated from the co-eluted components and there were no interferences from the endogenous material. The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 2.01±.05; 4.88±0.10 and 0.11 and 0.25 for TEL and RAM respectively on the basis of a signal to noise ratio. The ruggedness of the method at various parameters was found to be±1.94% and±1.02% for TEL and RAM respectively. The low values of %RSD (<2.0) for each of the drug proposed that during all deliberate variations, middle-quality control (MQC) was not affected and it was in accordance with that of actual.

Conclusion: Thus developed High-Performance Liquid Chromatography (HPLC) method was found to be more accurate, precise, sensitive, selective and reproducible.

Keywords: Ramipril, Telmisartan, Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) and Validation

References

1. Tripathi KD. Medical pharmacology. 6th ed. New Delhi: Jaypee Brothers; 2008. p. 501-8.
2. The United States Pharmacopoeia 29, National Formulary 24. Asian Edition. Rockville MD. United States Pharmacopoeial Convention, Inc; 2006. p. 501-8.
3. Rao KV, Vijaya Kumari K, Bhanuprakash I, Prabhakar G, Begum J. Determination of ramipril in pharmaceutical dosage forms by reversed-phase liquid chromatography. Asian J Chem 2006;18:788-92.
4. Belal F, Al-Zaagi IA, Gadkariem EA, Abounassif MA. A stability-indicating LC method for the simultaneous determination of ramipril and hydrochlorothiazide in dosage forms. J Pharm Biomed Anal 2001;24:335-42.
5. Rao RN, Sen S, Nagaraju P, Reddy VS, Radha Krishnamurthy P, Udaybhaskar S, et al. HPLC determination of Telmisartan in bulk and pharmaceutical formulations. Asian J Chem 2006;18:775–82.
6. ICH, Q2B-Validation of Analytical Procedures: Methodology, International Conference on Harmonization; 1996.
7. Salama I. Simultaneous HPLC–UV analysis of telmisartan and hydrochlorothiazide in human plasma. Bull Faculty Pharmacy Cairo University 2011;49:19-24.
8. Rajoriya V, Soni A, Kashaw V. Method development and validation of fast dissolving tablet of ramipril by HPLC method. Int J Pharm Pharm Sci 2016;8:174-8.
9. Madhukar A, Kannappan N, Mahendra Kumar CB. Analytical method development and validation for the determination of hydrochlorothiazide, amlodipine besylate and telmisartan hydrochloride in the multicomponent tablet dosage form and in biorelevant media (FASSIF) by RP-HPLC techniques. Int J Pharm Pharma Sci 2015;7:218-25.
10. Mahesh M, Kumanan R, Jayaveera KN. Isocratic RP¬-HPLC-¬UV method development and validation for the simultaneous estimation of hydrochlorothiazide and ramipril in tablet dosage form and bulk drug. Int J Curr Pharm Res 2011;3:119-23.
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How to Cite
Wal, P., Tiwari, R., Wal, A., & Tiwari, G. (2018). VERSATILE RP-HPLC METHOD DEVELOPMENT FOR QUANTITATIVE ESTIMATION OF TELMISARTAN AND RAMIPRIL IN ANIMAL PLASMA. International Journal of Applied Pharmaceutics, 10(4), 51-58. https://doi.org/10.22159/ijap.2018v10i4.24023
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